Journal of Clinical and Aesthetic Dermatology

Updates on Psoriasis & Cutaneou Oncology

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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Page 9 of 43

S10 P r o c e e D i n G s JCAD jOUrnAl Of ClInICAl And AEsthEtIC dErMAtOlOgy september 2017 • volume 10 • number 9 • supplement plaque psoriasis patients with moderate-to- severe disease. 4 Patients were randomized 3:1 to receive subcutaneous methotrexate (starting at 17.5mg/week with dose escalation in first eight weeks allowed up to a maximum of 22.5mg/week) or placebo over 16 weeks, then entered a maintenance phase of 36 more weeks, in which all patients were administered subcutaneous methotrexate. all patients received 5mg/week of folic acid throughout the study. By the 16th week, 41 percent of methotrexate and 10 percent of placebo patients had achieved a score of Pasi 75 (relative risk 3.9, 95% confdence interval [ci]: 31–11.81, p=0.0026). in the methotrexate arm, 31 percent had their dose escalated to the maximum of 22.5mg/week. an sPGa score of 0 (clear) or 1 (almost clear) was achieved by 27 percent in the methotrexate and seven percent in the control groups. in this study, there were no patient deaths, no major adverse cardiac events (Mace), and no malignancies, but adverse events occurred in 82 percent of the methotrexate and 93 percent of placebo patients during the double-blind phase and then in 78 percent of methotrexate and 77 percent of placebo patients during the open-label phase. these fndings contribute to the data about subcutaneous methotrexate and its potential eecacy and safety. second-generation biologics: tumor necrosis factor-a antagonists. Biologics are the mainstay of systemic psoriasis treatment. tumor necrosis factor (tnf)a antagonists include adalimumab, etanercept, ingiximab, golimumab, and certolizumab. Biosimilars for ingiximab, adalimumab, and etanercept have been approved or have been unanimously recommended to the fDa for approval. since psoriasis is inherently associated with increased cardiovascular risk, a retrospective study was conducted to evaluate the time to a Mace in patients receiving a tnfa inhibitor versus those receiving methotrexate. Data from the frst quarter of 2000 to the third quarter of 2011 were evaluated, and adult psoriasis patients with two or more prescriptions for either a tnfa antagonist or methotrexate were included (n=17,729). 5 overall, those who used tnfa antagonists had a lower incidence of cardiovascular adverse events compared to methotrexate users (hazard ratio [Hr]: 0.55, p<0.01); at 12 months; those using tnfa inhibitors had fewer cardiovascular events than those taking methotrexate (figure 2). the time to frst Mace among psoriasis patients showed that cumulative exposure to tnfa blockade lessens cardiovascular risk over time compared to methotrexate. 5 the hazard reductions dropped by 21.3, 38.0, and 51.2 percent for one, two, and three years, respectively, of tnfa blockade. further, cumulative exposure to tnfa blockade could be associated with an overall reduced risk for Mace. 5 Interleukin-23 p19 subunit inhibitors. Tildrakizumab. interleukin (il)-23 p19 subunit inhibitors include tildrakizumab, guselkumab, and risankizumab. reich et al reported results from the resurface1 trial (a study to evaluate the eecacy and safety of subcutaneous MK- 3222, followed by an optional long-term safety extension study, in Participants With Moderate- to-severe chronic Plaque Psoriasis [MK-3222-010] nct01722331) and resurface2 trial (a study to evaluate the eecacy and safety/tolerability of subcutaneous tildrakizumab [scH 900222/MK-3222] in Participants With Moderate-to-severe chronic Plaque Psoriasis followed by a long-term extension study [MK-3222-011] nct01729754), demonstrating that tildrakizumab achieved rates of Pasi 90 in almost 60 percent and Pasi 100 in 24 percent of patients with moderate-to- severe plaque psoriasis who were treated for 28 weeks. 6 the resurface2 study had four arms: tildrakizumab 200mg, tildrakizumab 100mg, etanercept 50mg, and placebo. at 12 weeks, placebo patients transitioned to one of the two tildrakizumab groups and remained there until Week 28. compared head-to-head, tildrakizumab odered signifcant improvements in the percentage of patients achieving Pasi 75 versus both placebo (p<0.001) and etanercept (p<0.05), and while PGa scores were signifcantly better for tildrakizumab versus placebo, the diderence achieved statistical signifcance versus etanercept only for tildrakizumab 200mg (p<0.05), but not the 100mg dose. 6 the proportion of patients having at least one adverse event in the resurface2 study was highest in the placebo group (55.1%), followed by etanercept (54.0%) and tildrakizumab 100 and 200mg (44.3% and 49.4%, respectively). adverse events culminating in withdrawal from the study happened in less than two percent of patients in all groups (highest in etanercept group at 1.9%, lowest in both tildrakizumab groups at 1.0%, 1.3% dropout rate in placebo patients). the most commonly reported adverse events were injection-site erythema and nasopharyngitis. Guselkumab. the results of the voyaGe 1 trial (a study of Guselkumab in the treatment of Participants With Moderate to severe Plaque- type Psoriasis nct02207231), a Phase 2, randomized, double-blind, placebo- and active- comparator-controlled study, were presented in 2016 and recently published. 7 Psoriasis patients were randomized to be treated with guselkumab 100mg (at Weeks 0 and 4, then every 8 weeks thereafter), adalimumab (80mg at Week 0, 40mg at Week 1, then 40mg every 2 weeks), or placebo for 16 weeks, then guselkumab for the open-label phase. compared to placebo, a signifcantly greater proportion of guselkumab patients scored 0

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